Medical Devices

Information on Medical Cribs Used in Homes and Child Care Settings

Example of pediatric medical cribs and proposed special controls

Consumer Product Safety Commission (CPSC) crib standards banning drop-side rail designs for consumer cribs took effect on June 28, 2011 for consumer crib manufacturers and retailers, and on December 28, 2012 for child care centers, family child care homes, and places of public accommodation (such as hotels). Current FDA regulation allows pediatric medical cribs used in health care settings to keep the drop-side rail feature because it is critical for providing appropriate medical care to sick children. The FDA realizes that in certain, uncommon situations, pediatric medical cribs with drop-side rails may need to be used outside of a health care setting.

The FDA issued a proposed rule FDA-2015-N-0701 on October 8, 2015, proposing new safety requirements for medical cribs and bassinets used in the treatment and care of pediatric patients which would allow them to be used outside of health care settings when prescribed by a physician. The proposed rule also proposes that slat width based on recommended standards and the mattress flammability requirements be consistent with those established by the CPSC. Also, the rule proposes separate safety requirements for pediatric medical cribs and pediatric medical bassinets, which are currently regulated as pediatric hospital beds.

The purpose of the proposed rule is to:

  • provide continued access by prescription use to pediatric medical cribs with drop-side rails in a home, child care or other facility when it is medically necessary;
  • further reduce potential risks associated with pediatric medical cribs and medical bassinets, such as entrapment or fire;
  • align applicable safety requirements for pediatric medical cribs with those of cribs for non-medical uses; and
  • provide manufacturers with clarity about FDA's safety expectations and requirements by providing more specific design requirements for pediatric medical cribs and medical bassinets.

The public will have the opportunity to comment on the proposed rule before the FDA develops and publishes the final rule. The FDA plans to finalize this rule after the FDA has reviewed the comments submitted to the proposed rule.

The FDA is aware that some child care facilities and family child care homes already have one or more pediatric medical cribs in their facility. Until the final rule is published, we encourage child care facilities with questions about pediatric medical cribs to contact their local or state licensing agencies to find out how the CPSC's final rule affects them.

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Pediatric Medical Devices

Page Last Updated: 10/07/2015
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